CompletedPhase 4

Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial

Italy120 participantsStarted 2021-10-01

Plain-language summary

The study compares the efficacy and safety of a Propionibacterium extract gel with 0.4% glyceryl trinitrate ointment in the treatment of chronic anal fissure.

Who can participate

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consecutive patients diagnosed with chronic anal fissure aged between 18 and 75 years Exclusion Criteria: * Fecal incontinence * Inflammatory bowel disease * Previous history of anal surgery * Previous or concomitant treatment for anal fissure, sexually transmitted disease, cancer, immune-suppressive treatment * Current pregnancy or breastfeeding * Known allergy to one of the agents contained into the evaluating drugs

What they're measuring

REALISE score

Timeframe: From baseline to visit 3 (40 days after the start of the treatment)

Trial details

NCT IDNCT05616455

SponsorTreviso Regional Hospital

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2022-03-31

View on ClinicalTrials.gov More Anal Fissure Chronic trials